Template/Guide for Product Information (PI) for Generic Products

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Background

  • The registration process of a generic product requires an application that encompasses Part I (Administrative Data and Product Information) and Part II (Quality) information.
  • Section A of Part I involves product particulars that will be translated into the package insert (PI) which is part of Section D.
  • According to the ASEAN Glossary used in the ASEAN Common Technical Dossier (ACTD) and Common Technical Requirements (ACTR), a package insert is a document defining information that are supplied with a pharmaceutical product by the marketing authorization holder (MAH).
  • Package inserts are required for products classified as Scheduled Poisons and they may also be submitted for Non Poisons (Over the Counter, OTC) products.
  • The draft copy of the package insert should be submitted for evaluation as it is a criteria to be fulfilled during the product registration process. The information furnished in the package insert must be identical to the information submitted in Section A of the application form.
  • During online applications for generic products, product information submitted by applicants (Section A and package insert) is sometimes inconsistent and there are variations between generic products and also with the innovator product.
  • The time for evaluation is affected as evaluators not only have to evaluate the information submitted in both sections but even correct grammatical errors and spelling mistakes.
  • For applicants on the other hand, many find it difficult to submit information based on registered products or relevant information as some references are not up-to-date or are not as approved by the Drug Control Authority (DCA).

Rationale for providing Template/Guide

  • These templates serve as a guide to applicants on product information based on the information approved for innovator products by the DCA.
  • The product information is general and not based on statistics or clinical trials by the innovator product. Therefore the information in these templates are suitable for generic products.
  • The product information is arranged according to the requirements for package inserts in accordance to the Drug Registration Guidance Document.
  • It will help applicants in submitting/providing product information (Section A and package insert) to ensure consistency in information for all registered generic products.
  • It will also help evaluators and ensure consistency during the evaluation process.
  • Hence, these templates can bridge the gap for both parties and improve the application and the evaluation process.
  • These templates are also furnished with Specific Labeling Requirements for the specific active ingredient (if applicable).

Implementation

  • The active ingredients for the templates created have been chosen based on the most common applications submitted to DCA and the number of templates will be increased from time to time.
  • The templates are prepared based on information from established references such as Micromedex and Martindale. However the indication is as approved for products registered by DCA
  • Updating of the product information/templates will be carried out if/when there are changes made to the innovator product information in terms of indication, dosage regimen as well as any new policy enforced by DCA.
  • Applicants are advised to use these templates in preparing information for Section A and package insert that is suitable with the dosage form of their products to be registered.

Scheduled Poisons

No

Active ingredient

Template/Guide

View (PDF)

1. 

Acyclovir (4)

Acyclovir Dispersible Tablet & Oral Suspension

Acyclovir Cream

Acyclovir Ophtalmic Ointment

Acyclovir Powder for IV Infusion

207 KB

143 KB

140 KB

178 KB

2. Adapalene (1) Adapalene Cream or Gel 181 KB
3. Alendronate (1) Alendronate Tablet 190 KB

4. 

Amlodipine (1)

Amlodipine Tablet

366 KB

5. Anagrelide Hydrochloride(1) Anagrelide Hydrochloride Capsule 224 KB

6.

Anastrozole (1)

Anastrozole Tablet

231 KB

7. Atenolol (1) Atenolol Tablet 354 KB

8.

Atorvastatin (1)

Atorvastatin Tablet

385 KB

9. Azelaic Acid (1) Azelaic Acid Cream or Lotion 248 KB

10.

Azithromycin (2)

Azithromycin Tablet & Powder for Oral Suspension

Azithromycin Powder for IV Solution

461 KB

439 KB

11. Baclofen (1) Baclofen Tablet 346 KB

12

Bisoprolol (1)

Bisoprolol Tablet

259 KB

13.

Captopril (1)

Captopril Tablet

282 KB

14. Carboplatin (1) Carboplatin Solution for Injection 181 KB

15.

Carvedilol (1)

Carvedilol Tablet

245 KB

16. Ceftazidime pentahydrate(1) Ceftazidime Powder for solution For Injection/Infusion 380 KB
17. Ceftriaxone sodium (1) Ceftriaxone Powder for solution For Injection/Infusion 379 KB
18. Cetirizine hydrochloride (1) Cetirizine Tablet/Oral Drops/Oral Solution 349 KB

19.

Cinnarizine (1)

Cinnarizine Tablet

171 KB

20. 

Ciprofloxacin (2)

Ciprofloxacin Tablet

Ciprofloxacin IV Infusion Solution

267 KB

335 KB

21. 

Clarithromycin (4)

Clarithromycin Tablet

Clarithromycin MR Tablet

Clarithromycin Granules for Oral Suspension

Clarithromycin Powder for IV Infusion

204 KB

222 KB

222 KB

 

217 KB

22. Clomiphene (1) Clomiphene Tablet 191 KB
23. Clopidogrel hydrogen sulphate/ bisulphate (1) Clopidogrel Tablet 373 KB
24. Clotrimazole Clotrimazole Vaginal Tablet 140 KB

25. 

Diclofenac sodium (5)

Diclofenac Sodium Enteric Coated Tablet

Diclofenac Sodium SR Tablet

Diclofenac Sodium Suppository

Diclofenac Sodium Solution for Injection

Diclofenac Sodium Eye Drop

226 KB

223 KB

205 KB

210 KB

159 KB

26. Docetaxel (1) Docetaxel Solution for Injection 227 KB

27.

Domperidone (1)

Domperidone Tablet & Oral Suspension

186 KB

28.

Donepezil (1)

Donepezil Tablet & Orodispersible Tablet

192 KB

29.

Epirubicin Hydrochloride(1)

Epirubicin Hydrochloride Intravesical Injection & Intravenous Infusion

280 KB

30. Etoricoxib (1) Etoricoxib Tablet 361 KB

31. 

Felodipine (1)

Felodipine ER Tablet

279 KB

32. Finasteride (1) Finasteride Tablet 179 KB
33. Gabapentin (1) Gabapentin Capsule/ Tablet 403 KB

34.

Gliclazide (2)

Gliclazide Tablet

Gliclazide MR Tablet

191 KB

196 KB

35.

Glimepiride (1)

Glimepiride Tablet

300 KB

36.

Granisetron (1)

Granisetron Tablet & Ampoule For Intravenous Injection / Infusion

186 KB

37. Irbesartan (1) Irbesartan Tablet 189 KB
38. Latanoprost (1) Latanoprost Eye Drop 225 KB

39.

Letrozole (1)

Letrozole Tablet

198 KB

40.

Loperamide Hydrochloride(1)

Loperamide Hydrochloride Capsule & Tablet

270 KB

41.

Loratadine (2)

Loratadine Tablet & Syrup

Loratadine Orodispersible Tablet

181 KB

172 KB

42.

Meloxicam (1)

Meloxicam Tablet & Capsule

202 KB

43.

Meropenem (1)

Meropenem Powder For Intravenous Injection & Infusion

185 KB

44. Metformin hydrochloride(2)

Metformin Tablet

Metformin Extended Release Tablet

348 KB

348 KB

45.

Montelukast (1)

Montelukast Tablet & Chewable Tablet & Granules For Oral Solution/Suspension

298 KB

46.

Olanzapine (2)

Olanzapine Tablet & Orodispersible Tablet

Olanzapine Powder for IM Injection

244 KB

 232 KB

47.

Quetiapine (2)

Quetiapine Tablet

Quetiapine ER Tablet

312 KB

306 KB

48.

Ranitidine (2)

Ranitidine Tablet, Effervescent Tablet, Effervescent Granules & Syrup

Ranitidine Solution for IV/IM Injection

181 KB

161 KB

49.

Risperidone (2)

Risperidone Tablet & Oral Solution

Risperidone ER Powder for IM Injection

212 KB

245 KB

50.

Salbutamol (4)

Salbutamol Injection & Salbutamol Solution For Intravenous Infusion

Salbutamol Metered Dose Inhaler

Salbutamol Respirator Solution & Salbutamol Solution For Inhalation

Salbutamol Tablet & Salbutamol Syrup

182 KB


185 KB

191 KB


182 KB

51. Silver Sulphadiazine (1) Silver Sulphadiazine Cream 330 KB

52.

Simvastatin (1)

Simvastatin Tablet

354 KB

53. Tamoxifen (1) Tamoxifen Tablet 199 KB
54. Tibolone (1) Tibolone Tablet 248 KB
55. Topiramate (1) Topiramate Tablet 212 KB

56.

Valsartan (1)

Valsartan Tablet

210 KB

57. Zolpidem (1) Zolpidem Tablet 254 KB

No

Active ingredient

Template/Guide

View (PDF)

1.

Acetylcysteine (1)

Acetylcysteine Granules

164 KB

2. Acetylsalicylic acid (2)

Acetylsalicylic acid 100mg dan 300mg enteric coated tablet

Acetylsalicylic acid 500mg

109 KB

 106 KB

3.

Activated Charcoal (1)

Activated Charcoal Tablet / Capsule / Granule / Powder

182 KB

4.

Albendazole (1)

Albendazole Tablet & Suspension

211 KB

5.

Ambroxol (1)

Ambroxol Tablet / Capsule / Lozenges / Elixir

187 KB

6.

Bisacodyl (1)

Bisacodyl Tablet & Suppositories

185 KB

7.

Bromhexine (1)

Bromhexine Tablet & Syrup/Elixir

170 KB

8.

Calamine & Zinc Oxide (1)

Calamine & Zinc Oxide Cream

155 KB

9.

Calcitriol (2)

Calcitriol Capsule

Calcitriol Injection

201 KB

179 KB

10

Cetrimide (1) Cetrimide Cream & Lotion 30 KB

11.

Chlorhexidine Gluconate(1) Chlorhexidine Gluconate 16 KB

12.

Clotrimazole (1)

Clotrimazole Cream / Lotion /   Solution/ Dusting Powder

170 KB

13.

Glucosamine(1)

Glucosamine Tablet/Capsule/

Sachet /Granules for Oral Solution

164 KB

14. Lactulose (1) Lactulose 94 KB

15.

Menthol & Camphor & Methyl salicylate (1)

Menthol & Camphor & Methyl salicylate Cream/ Ointment/ Liniment

178 KB

16 Oral Rehydration Salt (1) Oral Rehydration Salt 50 KB

17.

Paracetamol (3)

Paracetamol  Tablet

Paracetamol  Oral Suspension/Syrup

Paracetamol  Suppositories

213 KB

205 KB

212 KB

18.

Paracetamol and Caffeine(1) Paracetamol and caffeine Tablet 22.6 KB

19.

Simethicone (1)

Simethicone Tablet/Capsule

170 KB

20.

Sodium Chloride (1)

Sodium Chloride  0.9% w/v for IV Infusion

175 KB

21.

Terbinafine (1)

Terbinafine Cream / Gel

174 KB

22.

Water For Injection (1)

Water For Injection

 

157 KB

23. Guaiphenesin / Guaicol Glycerol Ether (1)

Guaiphenesin / Guaicol Glycerol Ether Tablet/ Capsule/ Syrup

 

30KB
24. Mecobalamine (2)

Mecobalamine Tablet & Capsule

Mecobalamin Injection

70KB

150 KB

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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  • Last Modified: Wednesday 12 December 2018, 16:48:53.
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